Apr 28, 2017

RIDGECREST HERBALS TO PHASE OUT HOMEOPATHICS IN FORMULAS

by Jamie Miller

Beginning in 2017, Ridgecrest Herbals has decided to phase out the homeopathic elements that exist in
some of our formulas. We expect the full process to take around two years as we carefully work to replace
the homeopathics with equally effective herbal components.Ridgecrest Herbals continues to believe in the
effectiveness and benefits of homeopathic remedies, but we feel that in the current hostile regulatory
atmosphere it is more beneficial for us as a company to remove homeopathy from our products. This decision
has come from a multitude of events in the industry:

Historically, homeopathic drugs were permitted to indicate suggested uses based on the Homeopathic
Pharmacopaeia of the United States (HPUS). These HPUS usage guidelines are based on homeopathic provings,
which are fundamentally different in nature than the clinical trials used by conventional drugs.
Traditionally, the FTC has not significantly regulated either advertising or labels of homeopathic
drugs, leaving the FDA to act as the primary regulatory agency for homeopathy.

For many years, the FDA has been opposed to combinations of homeopathics with other products such
as herbs, because homeopathics are regulated as drugs and herbs are generally regulated as supplements.
This makes it difficult to satisfy conflicting regulations with respect to formulation and labeling.

The FDA has recently taken the position that homeopathics should be subject to identity testing.
Because of the nature of the small dosages of the homeopathic tradition, this regulation is impossible
to satisfy with current science.

In November 2016, the Federal Trade Commission announced a new “Enforcement Policy Statement on
Marketing Claims for Over-the-Counter Homeopathic Drugs,” stating that “the FTC will hold efficacy and
safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.”
This position essentially adopts the “clinical-trial” standard applied to pharmaceuticals, and precludes
reliance on the HPUS. This will vastly increase the cost of traditional homeopathic medicines, or make
it very difficult for manufacturers to describe to consumers what the product is designed for.

In addition, homeopathy has recently become somewhat of a target for self-appointed “consumer
advocates” and professional plaintiffs who prey on parts of the natural products industry that they
feel are insufficiently “regulated” or “scientific.”

For all of these reasons, we have decided to discontinue our homeopathic/herbal combination products
and focus on our herbal formulas.

History of Homeopathy:

The theory of homeopathy was developed by German Physician Samuel Hahnemann at the turn of the 18th
century. He based his theory on the Greek philosophy of “like cures like”, the belief that a substance that
causes the symptoms of a disease in healthy people would cure similar symptoms in sick people. It is
believed Hippocrates prescribed a miniscule amount of mandrake root to cure mania, understanding that
larger doses would produce mania. The practice was a welcome shift from bloodletting, purging, and
medicines that could sometimes include lead, mercury, and opium. It gained popularity throughout the 19th
century, and helped pave the way for more scientific approaches to medical treatment. In 1938, before the
pharmaceutical industry became powerful as in modern days, the FDA recognized homeopathic preparations as
drugs.

Homeopathy Around the World:

Homeopathy is the second most-used natural medical system worldwide (next to Traditional Chinese Medicine),
with over 500 million people around the world incorporating it into their healthcare. The World Health
Organization has called for a greater acceptance of the practice as well as a push for more evidence-based
studies into the practice. In 2004, they produced a comprehensive list of every known study in the world,
and concluded that there was much evidence of its effectiveness, though more research was needed. In Europe,
homeopathy is supported and is an accepted form of natural practice, and many countries integrate it into
their state-subsidized health care systems, reimbursing for care, regulating and protecting homeopathic
drugs, and financing research. It is legally recognized in 42 countries, is written into the constitution
of Sweden and in Great Britain Queen Elizabeth is a patron of the Royal London Homeopathic Hospital, and
her husband, Prince Phillip, has played an active role in promoting the practice.

In the US, however, the road for homeopathics has been much more difficult, as the recent federal
developments prove. Natural medical alternatives have little federal lobbying power, and regulations such
as these hurt the ability for advocates of natural medicine to offer their services to the general public.
As a result, it can be difficult to describe exactly how a product works when you are not allowed to
properly or adequately explain what traditional methods, backed by hundreds of years of global efficacy,
believes them to do.

Conclusion:

Because of the difficulty of selling products while trying to work around the governmental oversight that
does not allow companies to properly describe the effects of their products, Ridgecrest Herbals has found
our homeopathic remedies in the crossfire. While homeopathy makes up less than 2% of our products by weight,
we do feel that their inclusion leads to better effectiveness than herbal remedies alone. Unfortunately, in
light of the current regulatory environment, they simply are not worth the fight. We will be researching
herbal alternatives in an attempt to improve on these formulas so they continue to be as effective as we
are proud they have always been. For some this will mean including products proven to increase
bioavailability, making the already existing ingredients more useful, and for others it may mean integrating
new herbs. While we are disappointed at what we see as an over-regulation of the natural products industry,
we are committed to providing quality products that meet all federal requirements, and we will work to
guarantee our products to be as powerful and effective as ever.